A successful Phase 3 trial and a public offeringof stock boosted prospects for this company to receive approval for an exciting new treatment.Capricor Therapeutics (CAPR 2.85%) stock rose an incredible 439.4% in December, according to data provided by S&P Global Market Intelligence. The move followed the company's announcement of positive top-line results from a Phase 3 trial of Deramiocel, a cell therapy for the treatment of Duchenne muscular dystrophy (DMD). However, the story is not quite as simple as a ...

– Webinar to be held Wednesday, December 17, 2025, at 1:00 p.m. ET – SAN DIEGO, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics, today announced that Parent Project Muscular Dystrophy (PPMD) will host a community webinar to share and discuss positive topline results from Capricor’s Phase 3 HOPE-3 trial evaluating Deramiocel, the Company’s investigational cell therapy for the treatment of Duche ...

Core Viewpoint - Investor Martin Shkreli's short position against Capricor Therapeutics has faced significant challenges following a major stock rally due to positive clinical trial results for its Duchenne Muscular Dystrophy treatment, Deramiocel [1][4]. Group 1: Company Overview - Capricor Therapeutics, based in California, focuses on developing therapies for Duchenne Muscular Dystrophy, with its primary asset being the HOPE-3 cell therapy [1]. - The company recently cleared a major regulatory hurdle, demonstrating strong evidence that Deramiocel can significantly improve the condition of patients with Duchenne muscular dystrophy [1]. Group 2: Stock Performance - Following the positive results from the phase-3 HOPE-3 trial, Capricor's stock surged by 440% in a single day, which adversely affected Shkreli's short position that anticipated a stock price around $2 per share [4]. - The stock's momentum score in Benzinga's Edge Rankings increased dramatically from 3.83 to 96.4 within a week, indicating a significant rise in trading volume and volatility [5]. Group 3: Market Reaction - The stock's momentum score spike reflects a broader market reaction to the positive clinical trial results, which often leads to increased investor interest and trading activity [3]. - The favorable price trend of Capricor's stock is noted across short, medium, and long-term time frames, suggesting sustained investor confidence [5].

Core Viewpoint - Capricor Therapeutics is in the process of a public offering to fund the development of its product candidates, particularly Deramiocel for Duchenne muscular dystrophy (DMD) [1][5] Group 1: Public Offering and Financials - The public offering is managed by Piper Sandler and Oppenheimer & Co., aimed at advancing Capricor's product candidates [1] - The company's current stock price is $26.89, reflecting a recent increase of approximately 5.87% [3] - Capricor's market capitalization is approximately $1.23 billion, with a trading volume of 7,007,389 shares, indicating strong investor interest [4] Group 2: Analyst Predictions - Analysts from Maxim Group and H.C. Wainwright have set optimistic price targets for CAPR, suggesting potential increases of approximately 98.56% and 99.65%, respectively [2][5] - On December 4, 2025, Maxim Group set a price target of $50 when the stock was trading at $25.18 [2] - H.C. Wainwright set a price target of $60 on December 3, 2025, when the stock was priced at $29.95 [2] Group 3: Stock Volatility and Market Activity - The stock has shown volatility, with a daily range between $26.01 and $28.63, and has experienced significant fluctuations over the past year, reaching a high of $40.37 and a low of $4.30 [3] - This volatility is typical for biotechnology stocks, which are often influenced by clinical trial results and regulatory news [3] - Capricor has a partnership with Nippon Shinyaku Co., Ltd. for the commercialization of Deramiocel in the U.S. and Japan, pending regulatory approval, which could enhance market reach and revenue potential [4]

Core Points - Capricor Therapeutics is hosting a conference call to discuss the HOPE-3 Phase III Topline Data [1] Group 1 - The call is being led by AJ Bergmann, the Chief Financial Officer of Capricor [1]

Group 1 - The article does not provide any specific content related to a company or industry [1]

Core Viewpoint - Capricor Therapeutics, Inc. has announced a public offering of 6,000,000 shares of common stock priced at $25.00 per share, aiming to raise approximately $150 million in gross proceeds to support its product development and general corporate purposes [1][2][3]. Group 1: Offering Details - The public offering consists of 6,000,000 shares at a price of $25.00 per share, with an additional 900,000 shares available for underwriters to purchase within 30 days [1] - The offering is expected to close around December 8, 2025, pending customary closing conditions [1] - Piper Sandler and Oppenheimer & Co. are the joint book-running managers, while H.C. Wainwright & Co. serves as the co-manager for the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the continued development and manufacturing of product candidates, working capital, and general corporate purposes [3] Group 3: Company Overview - Capricor Therapeutics focuses on developing cell and exosome-based therapeutics, with its lead product candidate, Deramiocel, in late-stage clinical development for Duchenne muscular dystrophy (DMD) [6] - Deramiocel has shown significant immunomodulatory and anti-fibrotic effects in preserving cardiac and skeletal muscle function in DMD patients [6] - The company is also advancing its proprietary StealthX™ platform for targeted delivery of therapeutics, with applications in vaccinology and treatment of various diseases [6] Group 4: Regulatory and Commercialization - The offering is conducted under an effective shelf registration statement filed with the SEC, ensuring compliance with regulatory requirements [4] - Capricor has an exclusive agreement with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of Deramiocel in the U.S. and Japan, pending regulatory approval [9]

在昨天（2025年12月3日），Capricor公司宣布Deramiocel的关键3期HOPE-3研究取得积极的总体结果，数据支持Deramiocel作为治疗杜氏心肌病的潜在首 选疗法。基于该结果，Capricor公司计划与FDA进行讨论之后，将包含HOPE-3数据的文件作为对完整CRL的回应。 Capricor公司指出，关键研究HOPE-3的结果，加上HOPE-2和HOPE-2 OLE研究的证据，能够解决早些时候收到的完整回应函中的临床问题，这与FDA此 前指导的一致，即HOPE-3研究结果应足以支持监管审批。 该消息发布后，Capricor公司股价应声暴涨，截止当日收盘，股价上涨371%。 | 最高：40.37 | 今开:30.00 | 成交量: 5695.91万股 | 换手:124.59% | | --- | --- | --- | --- | | 最低: 21.50 | 昨收:6.36 | 成交额：16.42亿 | 振幅: 296.70% | | 52周最高: 40.37 | 量比: 16.82 | 市盈率(TTM)：亏损 | 市净率：16.33 | | 52周景低: 4.30 | 委比:0.00% ...

Core Insights - Capricor Therapeutics announced positive top-line results from its pivotal Phase III HOPE-3 clinical trial for its investigational cell therapy Deramiocel in treating Duchenne Muscular Dystrophy (DMD), leading to a 371% increase in stock price to $29.96 on December 3, 2025 [1][5]. Group 1: Clinical Trial Results - The HOPE-3 trial was a randomized, double-blind, placebo-controlled study involving 106 patients with an average age of approximately 15 years [5][24]. - Deramiocel demonstrated a 54% reduction in disease progression in upper limb function (PUL v2.0) compared to placebo (p=0.029) and a 91% reduction in the decline of left ventricular ejection fraction (LVEF) (p=0.041) [6][11]. - The safety and tolerability of Deramiocel were consistent with previous clinical experiences [7][13]. Group 2: Regulatory Context - Capricor plans to respond to the Complete Response Letter (CRL) received from the FDA, believing that the HOPE-3 results, along with data from the HOPE-2 trial, will address the clinical questions raised by the FDA [10][15]. - The FDA previously rejected the approval based on the Phase II trial's inability to demonstrate efficacy for the pre-specified primary endpoint, but Capricor argues that the primary endpoint was indeed met with appropriate statistical methods [15]. Group 3: Implications for Patients - The results from HOPE-3 signify a new possibility for DMD patients, focusing on immune modulation to slow muscle and heart decline rather than gene repair or protein supplementation [17]. - While Deramiocel cannot reverse the disease, it may provide longer functional ability, more stable heart function, and improved daily life for patients [17]. Group 4: About Duchenne Muscular Dystrophy - Duchenne Muscular Dystrophy (DMD) is a severe X-linked genetic disorder characterized by progressive degeneration of skeletal, respiratory, and cardiac muscles, primarily affecting boys [18]. - Approximately 15,000 individuals in the U.S. are affected by DMD, with heart degeneration leading to cardiomyopathy and heart failure being the primary cause of death [18]. Group 5: About Deramiocel - Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs) known for their immune-modulating and anti-fibrotic properties, which have been shown to maintain cardiac and skeletal muscle function in DMD patients [21]. - The therapy has received orphan drug designation from the FDA and EMA for DMD treatment and has been recognized as a regenerative medicine advanced therapy (RMAT) in the U.S. [21]. Group 6: About Capricor Therapeutics - Capricor Therapeutics is a biotechnology company focused on advancing transformative cell and exosome therapies to redefine the treatment landscape for rare diseases, with Deramiocel being its leading product in late-stage clinical development for DMD [27].

Core Viewpoint - Capricor Therapeutics Inc. is gaining attention in the biotechnology sector due to its investigational treatment, Deramiocel, for Duchenne muscular dystrophy (DMD) [1] Stock Performance - Alliance Global Partners upgraded Capricor's stock to a "Buy" rating, increasing the price target from $16 to $48, with the stock priced at $29.19 at the time of the upgrade [2] - The stock has surged 263% to $23.09 after achieving a key goal in a late-stage study for a cell therapy related to a heart condition associated with DMD [2] - The stock reached an intraday high of $40.37, marking its highest levels since 2017, and has gained 87.6% year-to-date, driven by a short squeeze with short interest increasing by 15% [3] Recent Developments - Capricor faced a setback earlier in the year when the FDA denied approval for Deramiocel, resulting in a 33% drop in stock value [4] - The company plans to resubmit Deramiocel for approval, supported by positive results from its Phase 3 HOPE-3 trial involving 106 participants, which has boosted investor confidence [4] - Currently, CAPR is priced at $29.19, reflecting a 359% increase with a change of $22.83, and has a market capitalization of approximately $1.33 billion with a trading volume of 42.14 million shares [5]